BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3118883 · Received May 19, 2013

    Report

    Report Number
    3004209178-2013-07845
    Event Type
    Injury
    Date Received
    May 19, 2013
    Report Date
    April 23, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3387S-40, LOT # V020895, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD;, PRODUCT ID 7482A40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD 3 STROKES ¿IN THE PAST.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) STATED THAT THE PATIENT'S PROGRAMMER BATTERY DEPLETED AND HE JUST NEEDED A NEW 9V BATTERY. IT WAS REPORTED THAT THE PATIENT SHARED HIS HISTORY OF STROKES WHICH WERE NOT RELATED TO THE THERAPY. IT WAS NOTED THAT THERE WAS NOT PATIENT HOSPITALIZATION AND THERE WAS NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220796 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Other